Sr Regulatory Affairs Manager

Medtronic

Lafayette, Colorado, United States
Base: $154,400.00 - $231,600.00; bonus/equity: eli...
Onsite
7 years relevant experience
5 years managerial experience
Global regulatory strategy development
The Senior Manager leads the development and execution of global regulatory strategies to support worldwide product approvals and lifecycle management for the Acute Care and Monitoring airway product portfolio

Job Summary

  • The Senior Manager leads the development and execution of global regulatory strategies to support worldwide product approvals and lifecycle management for the Acute Care and Monitoring airway product portfolio.
  • This role requires onsite presence four days per week at the Lafayette, Colorado location and involves leading a team of regulatory professionals within a highly matrixed organization.
  • Medtronic offers a competitive salary range of $154,400.00 - $231,600.00 along with comprehensive benefits including health insurance, 401(k) matching, and incentive plans.

Matching Summary

The Senior Manager leads the development and execution of global regulatory strategies to support worldwide product approvals and lifecycle management for the Acute Care and Monitoring airway product portfolio.

Salary

Base: $154,400.00 - $231,600.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, dental, vision, 401(k), PTO, tuition assistance

Skills & Requirements

Must-have

  • 7 years relevant experience
  • 5 years managerial experience
  • Global regulatory strategy development
  • US FDA and EU Notify Body interactions
  • Medical device product lifecycle management

Nice-to-have

  • 10+ years medical device regulatory experience
  • Experience with EU MDR regulations
  • Leading cross-functional initiatives in matrixed organizations
  • Strategic thinking and decision-making skills

Key Requirements

  • Bachelor's degree with 7 years experience or advanced degree with 5 years
  • Minimum 5 years of managerial experience
  • Unrestricted US work authorization required
  • Strong knowledge of US FDA and EU MDR regulations

Work Rights

Must have unrestricted US work authorization

Tailored Resume

Cover Letter